ECRI has offered some recommendations for the FDA’s recently announced Home as a Healthcare Hub initiative.
The FDA initiative itself “involves creating an augmented reality/virtual reality-enabled home prototype hub. The goal is for device developers and other stakeholders to use the hub to visualize structural and design elements for more seamless integration of healthcare in the home setting, enabling patients to self-manage their clinical needs.”
ECRI, which has named “challenges with home-use medical devices the number-one health technology hazard of 2024,” offered up strategies for the FDA to consider. These strategies include increasing “user-centered testing for home-use devices,” prioritizing “cybersecurity in the connected home environment,” establishing a “method for home health patients to report device issues and get support,” and focusing on “ease of use in the design of device user interfaces, considering the needs of patients with physical limitations, disabilities, and varying levels of technology literacy.”
